Director, Global Patient Safety, Medical Safety Science

Location
Foster City, CA
Posted
Jan 25, 2022
Ref
2800763
Required Education
Bachelors Degree
Position Type
Full time
Director, Global Patient Safety, Medical Safety Science
United States - California - Foster CityUnited States – Remote

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible


Specific Responsibilities
  • Signal detection and authorship of signal work-up documents in collaboration with a Medical Safety Science Medical Evaluation (MSS-ME) team member
  • Authorship of Company Core Data Sheet (CCDS) sections and associated supporting documentation
  • Authorship of aggregate safety reports (e.g. PSURs)
  • Authorship of risk management plans
  • Authorship of responses to regulatory agency safety enquiries
  • Contribution to safety analyses in Regulatory submissions (e.g. Marketing Authorisation Application (MAAs), New Drug Application (NDAs))
  • May participate in literature review process on an ad hoc basis
  • Safety review of clinical trial protocols, investigator brochures, study reports, informed consent forms, and other study related documents for assigned studies
  • Reviews standard reference documents in collaboration with a MSS-ME team member
  • Collaborates with partner companies on safety evaluation for co-licensed products

Essential Duties and Job Functions
  • Chairs cross functional safety committee meetings (internal or with partner companies); able to present complex information clearly
  • Ensures timely review of protocols, informed consents and other study related documents for multiple products and therapeutic areas
  • Participates on and may lead various cross-functional teams, involving interaction with Gilead staff within and external to GLPS, to convey and acquire drug safety information internally and externally
  • Directs highly complex communications and ensures that all customers are fully informed and knowledgeable of project activities and their status
  • May recruit, hire, and manage direct reports, with responsibility for employee performance evaluations
  • Contributes to audits/inspections of systems and procedures to ensure the quality, integrity and compliance with pharmacovigilance and safety reporting regulations, including authoring of responses to findings relevant to functional area
  • Participates in both internal and external educational initiatives
  • May participate in budget planning and management
  • Identifies and pursues global and long-term goals for the group, in collaboration with department head, taking into account and providing support for the strategic goals of the organization
  • Acts as a mentor to junior employees
  • Leads one or more cross-functional projects with occasional supervision
  • Work is performed with only occasional supervision following established procedures
  • Recognized as an expert on pharmacovigilance, regulations, aggregate safety reports, risk management plans, signal detection, clinical trials, and clinical development within pharmacovigilance and by external departments
  • Presents results and findings and discusses processes in formal settings with consideration of the impact on processes within and external to GLPS and mentors more junior level employees in these activities
  • Leads safety review of regulatory documents
  • Recognized as a key representative within MSS functional area for the conduct and oversight of audits/inspections of systems and procedures for quality and compliance including authoring of responses to findings relevant to functional area
  • Works on extremely complex problems and provides solutions which will have significant impact

Knowledge, Experience and Skills
  • Demonstrates proficiency in verbal and written communication, including Microsoft Excel, Word, and Power Point
  • Demonstrates excellent attention to detail, teamwork and initiative; maintains confidentiality; maintains meticulous attention to project deadlines
  • Able to work independently, establishing work priorities and direction
  • Demonstrates excellent scientific/clinical and analytical knowledge base, with ability to assess data and understand the safety/medical implications
  • Sufficient skill and confidence to make significant contributions to strategic planning within the GLPS and epidemiology department
  • Demonstrates good understanding of observational studies used in pharmacoepidemiology and ability to provide a sound critique of such studies
  • Typically requires a degree (e.g., BS, BA, MSc or PhD) or professional qualification in a health science field (e.g., nursing or pharmacy) or a relevant scientific/technical discipline with demonstrated experience with the responsibilities, deliverables, and skills required for this level
  • Extensive experience (7+ years) in pharmacovigilance is required

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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.​

For more information about equal employment opportunity protections, please view the ‘EEO is the Law' poster.

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Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

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